Azelaic Acid

DEA Class; Rx

Common Brand Names; Azelex, Finacea

•  Acne Agents, Topical

Treatment for acne vulgaris and rosacea associated with inflammatory pustules and papules
Only topical formulations (cream, gel, foam) are marketed in the United States
Azelaic acid is a naturally occurring dietary constituent and can be formed endogenously

Indicated for the treatment of mild-to-moderate inflammatory acne vulgaris.

Hypersensitivity to azelaic acid, propylene glycol or any of its components

• Burning/ stinging/ tingling (4-16%)
• Pruritus (1-6%)
• Scaling/ dry skin/ xerosis (1-5%)
• Erythema/ irritation (1-2%)
• Contact dermatitis
• Edema
• Acne

In case of known hypersensitivity to any component of the gel, avoid the use of gel dosage form; if hypersensitivity develops during treatment, discontinue and institute appropriate therapy

For dermatologic use only

Therapy has been reported to cause irritation of eyes; avoid contact with eyes and mucous membranes; if medication comes in contact with eyes, wash eyes with large amounts of water and consult a physician if eye irritation persists

Isolated cases of hypopigmentation reported after azelaic acid use; monitor patients with dark complexion for early signs of hypopigmentation

Skin irritation (i.e. pruritus, burning or stinging) may occur, usually during first few weeks of treatment; if sensitivity or severe irritation develops and persists, discontinue treatment and institute appropriate therapy

Do not wax treated area or apply topical products that may further irritate skin (eg, astringents, abrasive soaps and cleansers, exfoliants)

Avoid any foods and beverages that provoke erythema, flushing, and blushing (eg, alcoholic beverages, spicy food, hot drinks such as hot coffee and tea)

Report any abnormal changes in skin color to physician

Avoid use of occlusive dressings or wrappings

Wash hands after applying the cream

Worsening of asthma reported; consult a physician if asthma is exacerbated with therapy

Azelaic acid is minimally absorbed systemically following topical route of administration; maternal use not expected to result in fetal exposure to drug

Azelaic acid is naturally present in human milk; when used as prescribed, azelaic acid is unlikely to be absorbed through skin in clinically relevant amounts to cause a change in azelaic acid concentration in milk or milk production; therefore, breastfeeding is not expected to result in exposure of infant to drug

Azelaic Acid

cream

• 20% (Azelex)

gel

• 15% (Finacea)

foam

• 15% (Finacea)